Fosinopril formulation

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Phosphorus containing other than solely as part of an...

Reexamination Certificate

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Reexamination Certificate

active

07045511

ABSTRACT:
A pharmaceutical formulation is provided comprising fosinopril which is the prodrug of an angiotensin converting enzyme (ACE) inhibitor, fosinoprilat. The formulation is characterized by comprising in the range of about 0.25 to about 5% glyceryl dibehenate which has been found to be a highly useful lubricant in the manufacture of tablets according to the present invention, enhancing the stability of fosinopril as compared to prior art formulations.

REFERENCES:
patent: 4337201 (1982-06-01), Petrillo, Jr.
patent: 5006344 (1991-04-01), Jerzewski et al.
patent: 2002/0131999 (2002-09-01), Sherman
patent: 2003/0109557 (2003-06-01), Foster
patent: 2005/0037068 (2005-02-01), Massironi
patent: 2005/0070557 (2005-03-01), Fryburg et al.
Gu, L. et al., “Drug-excipient Incompatibility Studies of the Pipeptide Angiotensin-Converting Enzyme Inhibitor, Moexipril Hydrochloride: Dry Powder Vs. Wet Granulation,”Pharmaceutical Research, vol. 7, No. 4, pp. 379-383 (Apr. 1990).
Al-Omari, M. et al., “Effect of the Drug-Matrix on the Stability of Enalapril Maleate in Tablet Formulations,”Journal of Pharmaceutical and Biomedical Analysis, vol. 25, No. 5-6, pp. 893-902 (Jul. 2001).

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